NEW YORK, NY -- (Marketwire) -- 10/30/12 -- The Food and Drug Administration Commissioner Margaret Hamburg has told scientific advisers that the FDA is considering a faster pathway for obesity treatments, life-saving antibiotics and other drugs deemed to offer societal benefit. The Paragon Report examines investing opportunities in the Biotech Industry and provides equity research on Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN) and Halozyme Therapeutics, Inc. (NASDAQ: HALO).
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Under the new pathway the FDA would allow developers of such drugs to conduct smaller, faster clinical trial, and provide a "special medical use" label which would allow doctors to administer drugs to patients with critical need. Hamburg has said that the FDA needs to take into account the needs people with deadly or debilitating diseases that may be willing to take on the risks of unproven drugs.
"A pathway that would allow products to come to market faster but would ensure they were used only in patients where there was an applicable risk-benefit situation would be good," said Pew Health Group's Allan Coukell, deputy director of medical programs. "It would be good for developers, for companies and it would be good for public health."
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Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease including HCV and resistant bacterial infections. The company last month reported positive proof-of-concept results with ACH-3102.
Halozyme is a biopharmaceutical company dedicated to the development and commercialization of products targeting the area outside the cell known as the extracellular matrix, or Matrix. The Matrix provides structural support in tissues and orchestrates many important biological activities, including cell migration, signaling and survival. The FDA last month allowed the company to resume clinical studies on Cinryze.
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